Prostate Cancer
Conditions
Interventions
Sponsors
None listed
Eligibility
Sex/Gender
Male
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Male patients aged more than 50 years old; 2. Histologically confirmed prostate cancer; 3. Clinically diagnosed as hormonal refractory carcinoma of prostate (HRPC): (1) Serum castration levels of testosterone. (less than 50 ng/ml); (2) Two consecutive rises of PSA 2 weeks apart defined as 2 successive increases with the first increase a minimum of 1 week from the baseline and the second increase a minimum of 1 week from the first increase; (3) A patient whose only evidence of progressive disease is an increasing PSA should have a value of at least 5 ng/mL before entering onto a clinical trial; (4) Documented PSA progression despite secondary hormonal manipulations*. 4. Either antiandrogen withdrawal or one secondary hormonal manipulation should have been done in order to fulfil the criteria for HRPC; 5. Antiandrogen withdrawal for at least 4 weeks for flutamide and 6 weeks for bicalutamide*. 6. With an Eastern Cooperative Oncology Group (ECOG) performance status 0-2; 7. Must have received their last radiation treatment at least 4 weeks earlier and their last dose of a therapeutic radionucleotide at least 8 weeks earlier; 8. Must at least 3 weeks since major operation.
Exclusion criteria
Exclusion criteria: 1. Patients with history of thromboembolic disease within previous 6 months; 2. severe uncontrolled cardiovascular disease; 3. Clinical significant neuropathy or other comorbid conditions; 4. Patients who have: (1) Serum creatinine levels > 200 umol/L (2.4 mg/dl); (2) Creatinine clearance 1.5 upper normal level.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point of this study is the anti-tumour response Defined as =50% reduction in serum PSA level maintained on two consecutive evaluations at least 4 weeks apart.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The start of the time to PSA progression is the day treatment is initiated. If at least a 50% decline in PSA has been achieved, the end date is the time the PSA has increased 50% above the nadir at a minimum of 5 ng/mL (this is the same as the parameter for PSA response).;For patients without a PSA decrease of this magnitude (or no decrease in PSA), the end point for progression will be calculated at the time a 25% increase in PSA has been achieved.;All end dates require a confirmatory PSA at least 4 weeks apart. Toxicity (National Cancer Institute Common Toxicity Criteria version 2.0); | — |
Countries
China
Contacts
Public ContactChi-Fai NG
Outcome results
None listed